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Latest From David Wallace
FDA Guides On Bioequivalence Studies And COVID-19
Guidance on protecting participants in bioequivalence studies during the COVID-19 pandemic has been published by the FDA.
Teva Takes On Amneal With Second US NuvaRing Rival
Teva has launched its generic version of NuvaRing in the US, adding a second rival generic to the market that already includes Amneal, as well as an authorized generic version from Prasco.
New UK Biosimilars Pathway Suffers Setback
The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.
Hikma Suspends Roll-Out Of Advair Rival
Hikma has temporarily stopped the roll-out of its rival to Advair Diskus in the US after it filed an amendment to its ANDA over packaging controls.
Celltrion Gets Ready For Denosumab Phase III
Celltrion has kicked off plans for a Phase III trial for its denosumab biosimilar rival to Prolia.
Haruvi Takes Charge Of Sandoz North America
Novartis has appointed its former global head of M&A, Keren Haruvi, to take over from Carol Lynch as president of Sandoz US and head of North America.